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Opioid Risk Assessment Tool for Opioid Use Disorder (PharmTool Trial)
N/A
Waitlist Available
Led By Jerry Cochran, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
PharmTool Trial Summary
This trial will assess the impact of a new opioid medication risk screener and decision support platform to reduce risk status in two pharmacy divisions.
Who is the study for?
This trial is for pharmacies in the Cincinnati or Columbus, Ohio areas. It's not for individual patients; instead, entire pharmacies will participate to see if a new tool helps manage opioid risks better than usual care.Check my eligibility
What is being tested?
The study tests an Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool against standard care in pharmacies. Pharmacies are randomly chosen to use either the ORRCDS tool or continue with their regular process when dispensing opioids.See study design
What are the potential side effects?
Since this trial involves the use of a decision support tool rather than direct patient treatment, there are no medical side effects associated with its implementation.
PharmTool Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Stage 1: Development of the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool
Stage 2: Improvement in patient opioid-related risks
Stage 3: ORRCDS sustainability within the system and pharmacy chain systems
PharmTool Trial Design
2Treatment groups
Experimental Treatment
Group I: Intervention Pharmacy SiteExperimental Treatment2 Interventions
Pharmacies randomized to the experimental arm will be exposed to the intervention condition.
Patients at the intervention pharmacy identified as at elevated risk will receive confirmatory screening for opioid risk. Those with confirmed moderate risk will receive a brief motivational intervention for medication misuse and an offer of naloxone dispensation. Those with high risk will receive a brief motivational intervention leading to warm handoff treatment linkage intervention to primary or specialty substance use care with an offer for naloxone dispensation.
Group II: Control Pharmacy SiteExperimental Treatment1 Intervention
Standard of Care is the treatment as usual condition, which follows federal and Ohio state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. Ohio State law requires pharmacist to not dispense an opioid supply >90 days, with a specific prohibition on dispensations ≥14 days after prescriptions are issued. Pharmacists are also required to perform a universal prescription drug medication review before initial dispensation and offer brief counseling (e.g., unstandardized information about medication safety) for new/modified prescription therapies.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,642 Total Patients Enrolled
University of CincinnatiOTHER
428 Previous Clinical Trials
634,306 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,268 Total Patients Enrolled
5 Trials studying Opioid Addiction
648 Patients Enrolled for Opioid Addiction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Not applicable.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Pharmacy Site
- Group 2: Control Pharmacy Site
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this medical trial?
"The clinical trial in question, originally listed on March 1st 2024 and edited lastly January 20th of the same year is not currently accepting applicants. However, 294 other medical trials are actively looking for patients at this point in time."
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